This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris (NCT03073213), a randomized phase 1 study. The primary outcome is Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03073213 |
| Phase | Phase 1 |
| Condition | Psoriasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Chinese participants with psoriasis vulgaris were enrolled in a Phase 1 study. The registry record reports overall enrollment of 32. The primary pharmacokinetic population was defined as randomized participants in a multiple-dose group who received at least one dose of ixekizumab and had evaluable pharmacokinetic data. The posted primary results include 14 participants in each of the two multiple-dose groups.
Intervention
Ixekizumab was given by subcutaneous injection. The single-dose group received 80mg. In the multiple-dose groups, treatment began with a 160mg initial dose, followed by 80mg either every two weeks (Q2W) or every four weeks (Q4W).
Comparator
The posted primary outcome gives separate pharmacokinetic summaries for the Q2W and Q4W regimens. The registry record does not report a placebo or untreated group. It labels the Q2W multiple-dose group as the control for the posted outcome, but reports no formal analysis comparing the regimens.
Primary question
The primary endpoint asks what maximum observed serum concentration of ixekizumab was reached during multiple dosing. The registry reports geometric mean Cmax values and geometric coefficients of variation for the two schedules. The posted endpoint is pharmacokinetic, not a measure of psoriasis response. A treatment-effect estimate, confidence interval, or hypothesis test comparing schedules is not reported in the registry record.
3. Trial Design
This was a randomized, open-label, parallel-group Phase 1 study of ixekizumab in Chinese participants with psoriasis vulgaris. It had a single-dose part and a multiple-dose part. The registry record reports enrollment of 32 and a completed status. The recorded study start was 2017-04-13, and primary completion was 2019-05-14.
The single-dose group received a single 80mg subcutaneous dose. In the multiple-dose part, one group received a 160mg initial dose followed by 80mg every two weeks; another received a 160mg initial dose followed by 80mg every four weeks. The record describes the study purpose as assessing how much ixekizumab enters the bloodstream, how long the body takes to get rid of it, and its safety and associated side effects. The stated study durations, including screening, were up to 24 weeks for the single-dose part and up to 32 weeks for the multiple-dose part.
Randomization and a parallel model are recorded, but the randomization method, allocation ratio, and procedures used to conceal the allocation are not reported in the registry record. Masking is recorded as none. The record does not report a placebo group or a clinical efficacy comparison. The primary pharmacokinetic outcome is based on participants in the multiple-dose groups who received at least one dose and had evaluable pharmacokinetic data. The posted primary summaries include 14 participants in each regimen group. The registry record does not explain how these endpoint populations relate to the overall enrollment or to the denominators used for safety outcomes.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Single Dose Period
| Stage | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose |
|---|---|---|---|
| STARTED | 12 | 0 | 0 |
| COMPLETED | 12 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Multiple Dose Period
| Stage | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose |
|---|---|---|---|
| STARTED | 0 | 14 | 15 |
| Participants Enrolled From Single Dose | 0 | 7 | 2 |
| COMPLETED | 0 | 14 | 14 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose |
|---|---|---|---|
| Protocol Violation | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
| Characteristic | Unit | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose | Total |
|---|---|---|---|---|---|
| Participants analysed | 12 | 14 | 15 | 41 | |
| Age, Continuous: Single Dose | years | 49.0 (SD 12.1) | — | — | 49.0 (SD 12.1) |
| Age, Continuous: Multiple Dose | years | — | 45.6 (SD 12.5) | 45.5 (SD 16.1) | 45.6 (SD 14.2) |
| Sex: Female, Male: Single Dose – Female | Participants | 2 | 0 | 0 | 2 |
| Sex: Female, Male: Single Dose – Male | Participants | 10 | 0 | 0 | 10 |
| Sex: Female, Male: Multiple Dose – Female | Participants | 0 | 3 | 5 | 8 |
| Sex: Female, Male: Multiple Dose – Male | Participants | 0 | 11 | 10 | 21 |
| Ethnicity (NIH/OMB): Single Dose Phase – Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Single Dose Phase – Not Hispanic or Latino | Participants | 12 | 0 | 0 | 12 |
| Ethnicity (NIH/OMB): Single Dose Phase – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Multiple Dose Phase – Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Multiple Dose Phase – Not Hispanic or Latino | Participants | 0 | 14 | 15 | 29 |
| Ethnicity (NIH/OMB): Multiple Dose Phase – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – Asian | Participants | 12 | 0 | 0 | 12 |
| Race (NIH/OMB): Single Dose Phase – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Single Dose Phase – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – Asian | Participants | 0 | 14 | 15 | 29 |
| Race (NIH/OMB): Multiple Dose Phase – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Multiple Dose Phase – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: China – Single Dose | Participants | 12 | 0 | 0 | 12 |
| Region of Enrollment: China – Multiple Dose | Participants | 0 | 14 | 15 | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose), measured over day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | Microgram per milliliter (ug/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is maximum observed serum concentration of ixekizumab, called Cmax, during multiple dosing. It is reported in micrograms per milliliter (ug/mL), with a geometric mean as the summary measure and a geometric coefficient of variation as the measure of dispersion. The registry specifies measurements from day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, and 197.
Cmax describes the highest observed concentration in the serum over the stated sampling schedule. In pharmacokinetic research, concentration measurements help characterize drug exposure in the body. The geometric mean is a way to summarize measurements that are positive and may be distributed asymmetrically; the geometric coefficient of variation conveys relative variability around that summary. These are general statistical interpretations of the measures, not evidence about clinical benefit.
The posted geometric mean Cmax is 19.9 for the Q2W group and 13.4 for the Q4W group. The corresponding geometric coefficients of variation are 27.0 and 32.0. The registry record does not report confidence intervals for these values, a formal between-group estimate, or a statistical test. Cmax does not by itself indicate symptom improvement, long-term safety, or how an individual participant’s concentration changed over time.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary multiple-dose pharmacokinetic endpoint, the registry reports a geometric mean Cmax of 19.9 in the Q2W group and 13.4 in the Q4W group. Each posted group includes 14 participants. The corresponding geometric coefficients of variation are 27.0 and 32.0. These summaries describe the observed concentration data in the stated pharmacokinetic population; they do not constitute a reported test of whether the dosing schedules differ.
The geometric mean is a central summary of the measured concentrations. The geometric coefficient of variation describes relative dispersion, so the values indicate that concentrations varied among participants in both groups. Neither measure is a confidence interval. The registry record does not provide confidence intervals or another measure that would quantify the precision of the group summaries, nor does it report an adjusted or unadjusted contrast between regimens.
Because the endpoint is Cmax, its interpretation is limited to the maximum observed serum concentration over the sampling schedule. It is not a clinical outcome such as a change in psoriasis severity. The registry record also describes interest in how long the body takes to get rid of the drug, but the posted primary endpoint is Cmax; a specific elimination estimate is not reported in the registry record.
The record labels the Q2W arm as the control for this outcome, but the result is presented as two arm-level summaries rather than a formal contrast. The difference in the displayed values should not be treated as an estimated treatment effect, and no significance claim is supported by the posted primary results. Randomization is recorded, but the record does not describe the allocation method, analysis model, or any adjustment for other variables.
The safety counts are also descriptive. Serious adverse events affected 0 participants in the single-dose group, 1 in the Q2W group, and 0 in the Q4W group, using the arm-specific denominators recorded for safety. Other adverse events affected 11 of 12 participants in the single-dose group, 11 of 14 in Q2W, and 12 of 15 in Q4W. Deaths are recorded as 0 in each group. These counts do not establish comparative safety, particularly without a concurrent placebo group, a reported analysis plan, or information about exposure-adjusted rates.
Overall, the posted results provide descriptive pharmacokinetic and safety information for this Phase 1 study. The registry record does not report a formal comparison, inferential uncertainty for the primary summaries, or posted secondary outcome results. The evidence should therefore be read as a set of observed summaries rather than a definitive estimate of differences between schedules or a clinical efficacy finding.
9. Statistical Methods Explained
The posted primary result uses a geometric mean for Cmax and a geometric coefficient of variation for dispersion. These measures suit concentration data that are positive and may be skewed. In general, a geometric mean summarizes values on a multiplicative scale, while a geometric coefficient of variation describes relative variability. Neither is a measure of uncertainty in the estimated group mean. A confidence interval, if reported, would convey uncertainty in an estimate; no confidence interval for the primary result is reported in the registry record.
What does randomization contribute?
Random allocation can help balance participant characteristics across groups on average, reducing some forms of selection bias in a comparative study. The registry record identifies the study as randomized, but the randomization sequence, allocation ratio, and allocation concealment procedures are not reported. The primary endpoint is shown as arm-specific summaries, and no formal contrast is posted. Randomization alone does not turn separate descriptive summaries into a reported statistical comparison.
How should the two dosing schedules be read?
The multiple-dose regimens share a 160mg initial dose followed by 80mg subcutaneous injections, with different intervals: Q2W and Q4W. The reported Cmax summaries are 19.9 and 13.4, respectively, with 14 participants in each group. Since the record does not report a contrast, standard error, confidence interval, or hypothesis test, the numerical separation between these summaries should not be interpreted as evidence of a statistically established difference. The record also does not report whether any analysis adjusted for baseline characteristics or other factors.
What does the dispersion measure tell readers?
The geometric coefficients of variation are 27.0 for Q2W and 32.0 for Q4W. They describe relative variability in concentrations within the groups, not the precision of the group-level estimate. In general, substantial variation between participants can make a group summary less representative of any one participant. The record does not provide participant-level concentrations or confidence intervals, so the range and precision of individual or group values cannot be assessed from the posted summaries alone.
Why can over-dispersion matter?
As a general statistical point, over-dispersion occurs when data vary more than a model assumes. If a model does not account for that extra variation, its uncertainty estimates can be too small and statistical tests can be misleading. The record does not report a model for the primary outcome or describe an assessment of over-dispersion. The posted geometric coefficient of variation indicates variability, but it is not by itself a test for over-dispersion and does not reveal which model, if any, was used.
What can planning calculations establish?
Sample-size illustrations based on an observed effect are planning exercises. They describe the number of participants per arm that a hypothetical future study might require under stated assumptions, such as a significance level, allocation, and target power. They are not observed power for the completed trial, and they do not show that the study was adequately or inadequately powered for its original aims. The registry record does not report the study’s sample-size justification or its planned statistical power. No additional sample-size calculation is needed to interpret the posted geometric means.
What is not available for an inferential reading?
The registry record reports no posted analysis for the primary outcome in the analysis field and does not provide a formal between-group estimate. It also does not report confidence intervals, a test statistic, a p-value, covariate adjustment, or a statistical model for the Cmax summaries. These omissions limit how precisely readers can compare the regimens. Descriptive values remain useful for understanding the reported concentrations, but the posted information does not quantify uncertainty around a regimen contrast.
For safety, the registry gives counts of participants affected by serious and other adverse events, along with deaths. Counts are straightforward descriptive summaries, but they are not necessarily comparable without consistent follow-up, exposure time, event definitions, and analysis populations. Those details are not reported in the registry record. General statistical interpretation therefore calls for treating these safety data as counts within the recorded groups, rather than as proof of a difference or equivalence in risk.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 5 outcome measures, but reports 0 posted secondary outcomes. The primary endpoint is maximum observed concentration during multiple dosing. It does not report a multiplicity adjustment, a hierarchy of hypotheses, or how the statistical analysis addressed the possibility of multiple outcomes or comparisons. The record also gives no formal inferential comparison for the posted primary summaries. The planned statistical approach, including any control of type I error across outcomes, is not reported in the registry record.
The record identifies the primary pharmacokinetic population as randomized participants in a multiple-dose group who received at least one dose and had evaluable pharmacokinetic data. This defines who could contribute to the reported endpoint, but the number screened, randomized by group, excluded from the analysis, or missing endpoint data is not reported in the registry record. The record does not describe imputation, missing-data assumptions, sensitivity analyses, or how measurements below a quantification limit were handled.
For safety, the at-risk denominators are 12 in the single-dose group, 14 in Q2W, and 15 in Q4W. Those denominators differ from the posted primary pharmacokinetic group counts, and the registry record does not explain the relationship between these analysis populations. No participant flow or accounting of withdrawals is included in the registry entries. The overall enrollment is recorded as 32, but the record does not reconcile that figure with the separate denominators used for the posted results.
These gaps matter because multiplicity decisions, endpoint missingness, and analysis-population choices can affect interpretation. Without the statistical analysis plan or fuller participant accounting, readers cannot determine whether all planned outcomes and analyses are represented in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ixekizumab Single Dose | 0 | 12 | 0.0% |
| Ixekizumab 80mg Q2W Multiple Dose | 1 | 14 | 7.1% |
| Ixekizumab 80mg Q4W Multiple Dose | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ixekizumab Single Dose | 0 of 12 |
| Ixekizumab 80mg Q2W Multiple Dose | 0 of 14 |
| Ixekizumab 80mg Q4W Multiple Dose | 0 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ixekizumab Single Dose | 11 of 12 |
| Ixekizumab 80mg Q2W Multiple Dose | 11 of 14 |
| Ixekizumab 80mg Q4W Multiple Dose | 12 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose |
|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | 0 of 12 | 1 of 14 | 0 of 15 |
| Cholecystitis | Hepatobiliary disorders | 0 of 12 | 1 of 14 | 0 of 15 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 12 | 1 of 14 | 0 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ixekizumab Single Dose | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose |
|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | 5 of 12 | 6 of 14 | 2 of 15 |
| Upper respiratory tract infection | Infections and infestations | 2 of 12 | 5 of 14 | 3 of 15 |
| Electrocardiogram abnormal | Investigations | 1 of 12 | 3 of 14 | 2 of 15 |
| Protein urine present | Investigations | 4 of 12 | 2 of 14 | 0 of 15 |
| Diarrhoea | Gastrointestinal disorders | 0 of 12 | 3 of 14 | 2 of 15 |
| Nasopharyngitis | Infections and infestations | 2 of 12 | 1 of 14 | 1 of 15 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 2 of 12 | 0 of 14 | 2 of 15 |
| Urticaria | Skin and subcutaneous tissue disorders | 2 of 12 | 1 of 14 | 1 of 15 |
| Anaemia | Blood and lymphatic system disorders | 1 of 12 | 2 of 14 | 0 of 15 |
| Flatulence | Gastrointestinal disorders | 3 of 12 | 0 of 14 | 0 of 15 |
Serious events with the highest arm-level rate: bile duct stone (7.1%), cholecystitis (7.1%), cholelithiasis (7.1%).
Serious adverse event counts are recorded by group: 0 of 12 participants in the single-dose group, 1 of 14 in the Q2W group, and 0 of 15 in the Q4W group. Deaths are recorded as 0 in all three groups. These figures describe the number of participants affected according to the registry record; they do not provide a comparison adjusted for follow-up time or exposure.
The registry also lists bile duct stone, cholecystitis, and cholelithiasis among the top serious terms, each at 7.1%. The record does not identify a group-specific denominator for these term percentages in the registry record, so they should not be attributed to a particular regimen. The listed term percentages should not be combined or interpreted as distinct participants, since the record does not explain overlap or the counting method.
Other adverse events affected 11 participants in the single-dose group, 11 in Q2W, and 12 in Q4W, with at-risk counts of 12, 14, and 15, respectively. These are descriptive counts and do not establish that one regimen has a higher or lower risk. Definitions, event-specific detail, follow-up duration by participant, and a comparative safety analysis are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted primary result describes serum ixekizumab concentrations during multiple dosing. The geometric mean Cmax is 19.9 in the Q2W group and 13.4 in the Q4W group, with 14 participants in each. The geometric coefficients of variation are 27.0 and 32.0. These values communicate the central concentration summaries and relative variability observed in the defined pharmacokinetic population.
They do not establish that one dosing schedule produces a statistically different maximum concentration. The registry record does not report a confidence interval, formal between-group estimate, or hypothesis test. It also does not report a clinical efficacy endpoint among the posted results. Cmax is a pharmacokinetic measure, not a direct measure of psoriasis improvement, quality of life, or sustained disease control.
The study was Phase 1 and described its aims as pharmacokinetics and safety. Its randomized, open-label, parallel design is recorded, but the record does not provide details of randomization or the statistical analysis plan. The absence of a reported placebo group and the descriptive presentation of results mean the posted figures should not be read as evidence that ixekizumab is better or worse than another treatment.
Safety counts describe events among participants in the recorded groups. They do not show that an event was caused by treatment, and they do not allow a reliable comparative risk estimate without fuller details on exposure, follow-up, event ascertainment, and analysis. The serious event counts are low in the posted group summaries, but that fact alone cannot establish the absence of risk. The record reports no deaths in the listed groups.
In general, a small early-phase study can characterize pharmacokinetic measurements and identify safety observations worth further study, but its summaries do not automatically generalize to other populations or settings. The registry record does not report a justification for enrollment, a precision target, or a planned power calculation. The posted data support a descriptive reading of concentration and event summaries, with important uncertainty about comparative effects and broader applicability.
13. Why This Trial Matters Statistically
This study is statistically useful because it illustrates the difference between a pharmacokinetic summary and a clinical treatment-effect estimate. The primary result is a geometric mean Cmax, paired with a geometric coefficient of variation. Those statistics describe measured drug concentrations and their variability; they do not answer whether psoriasis outcomes differ between schedules.
The record also makes clear why a randomized design and a reported comparison are distinct features. Randomization is recorded, but the posted primary results are separate arm summaries. Without a formal contrast and uncertainty measure, readers cannot determine how precisely the regimens differ according to the study’s analysis. A difference between displayed summaries is not, on its own, a test of that difference.
Another statistical lesson is that analysis populations and denominators should be explicit. The primary pharmacokinetic population is defined by receipt of at least one dose and evaluable data, while safety denominators are reported separately. Overall enrollment is also given. The relationship among these figures is not explained in the registry record, which limits assessment of exclusions and missing data.
The safety results likewise show the limits of simple counts. Adverse event counts are useful for describing what was recorded, but interpreting comparative risk requires details about follow-up, exposure, definitions, and analysis. Those details are not reported in the registry record. The serious event terms are listed with percentages, but their group attribution is not specified in the registry record.
Finally, planning illustrations derived from observed effects should not be confused with observed power or with the trial’s original design rationale. The registry record does not report its sample-size justification or planned statistical approach. Keeping descriptive summaries, inferential evidence, safety signals, and future-study planning conceptually separate is essential to a cautious statistical reading.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record provides limited detail about how the trial was conducted and analyzed. Although it identifies randomized allocation, open-label masking, and a parallel model, it does not report the sequence-generation method, allocation concealment, allocation ratio, or statistical analysis plan. These omissions make it difficult to assess the procedures behind the group assignment and the analysis of the posted endpoint.
The primary result is limited to geometric means and geometric coefficients of variation for two multiple-dose groups. Confidence intervals, a formal regimen contrast, hypothesis tests, and participant-level measurements are not reported. Consequently, the precision of the group summaries and the uncertainty in any between-regimen difference cannot be evaluated from the registry record.
The record states overall enrollment of 32, while the endpoint and safety results use distinct group counts. It does not provide participant flow, explain exclusions, identify missing measurements, or reconcile the relationship among the denominators. Missing-data methods and sensitivity analyses are not reported. The record also does not specify how the serious adverse event term percentages were assigned to groups or calculated.
There is no posted secondary outcome result despite the listing of 5 outcome measures. The record does not report a multiplicity strategy or describe whether all planned outcomes and analyses appear in the registry. It also does not provide a sample-size justification or explain the intended precision of the pharmacokinetic estimates. These limitations restrict interpretation to the descriptive results and study characteristics that are explicitly recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris — NCT03073213.
- Registry record last updated 2020-07-22; status last verified 2019-06-01.
- Results first posted 2020-07-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03073213 is a completed Phase 1 randomized, open-label, parallel study of ixekizumab in Chinese participants with psoriasis vulgaris. Overall enrollment is recorded as 32. The study included a single-dose group and two multiple-dose regimens: 80mg once, or a 160mg initial dose followed by 80mg every two weeks or every four weeks.
The primary endpoint was maximum observed serum concentration during multiple dosing. The posted geometric mean Cmax values were 19.9 for Q2W and 13.4 for Q4W, with geometric coefficients of variation of 27.0 and 32.0, respectively; each group included 14 participants. No formal contrast or confidence interval is reported in the registry record.
Safety results list serious adverse events in 0 of 12 single-dose participants, 1 of 14 Q2W participants, and 0 of 15 Q4W participants, with 0 deaths in each group. The record does not explain the differing analysis denominators or provide a posted secondary outcome analysis.